All Recalls

95,050 total recalls in our database

Abbott ARCHITECT c8000 Processing Module, List No. 01G06 - Product Usage: The Abbott ARCHITECT System is intended for In Vitro diagnostic use only. The Abbott ARCHITECT Clinical Chemistry Systems are designed to perform automated chemistry tests, utilizing photometry and potentiometric technology. The ARCHITECT c4000, c8000, c16000 sample pipettor assemblies include a fluid sense/pressure monitoring system that helps identify errors in aspiration.

Abbott Laboratories

🏥 Medical Devices Class I - Dangerous

There is a potential to generate incorrect results on the instrument if particular error codes are not resolved before transitioning to the Running status.

Jul 17, 2018 Diagnostic Equipment Nationwide View Details →

Beaver Xstar Slit Knife 2.4 mm, 45degree Double Bevel, Ophthalmic-utilized in Cataract and Glaucoma procedures REF # 370824 Product Usage: Ophthalmic techniques-utilized in Cataract and Glaucoma procedures

Beaver Visitec

🏥 Medical Devices Class I - Dangerous

Mislabeled. The package labeling indicates a size 2.4mm, 45 degree Double Bevel knife however, the marking on device shows a 2.75mm size device

Mar 12, 2019 Other Medical Devices Nationwide View Details →

Edwards Lifesciences(R) IntraClude(TM) Intra-Aortic Occlusion Device is a 10.5 Fr (3.5mm), triple lumen, 100cm long catheter with an elastomeric balloon near its distal tip designed to occlude the ascending aorta in order to partition the aortic root from arterial circulation. The balloon expands to occlude a range of aorta sizes from 20 to 40 mm. The large central lumen of the IntraClude Device serves three functions: accommodating the guidewire, delivering cardioplegia solution to the aortic root, and venting fluid and air from the aortic root. The two remaining lumens serve as conduits for balloon inflation/deflation and aortic root pressure monitoring.

Edwards Lifesciences

🏥 Medical Devices Class I - Dangerous

Edwards Lifesciences has received a limited number of customer reports regarding an inter-lumen leak between the cardioplegia lumen and pressure lumen in the device.

Jan 16, 2019 Diagnostic Equipment Nationwide View Details →

Arrow¿ Two-Lumen Central Venous Catheterization Kit with Blue FlexTip¿ Catheter Product Code: AH-11802 (OUS) GTN: 00801902026132

Arrow International

🏥 Medical Devices Class I - Dangerous

The product lidstock contains a labelling error. The lidstock states the incorrect priming volume. The priming volumes printed on the extension lines are correct

Jan 10, 2019 Surgical Instruments View Details →

syngo.via syngo.CT Cardiac Function, Model Number 10496180 Product Usage: Syngo.CT Cardiac Planning and syngo CT. Cardiac Function are image analysis software packages for evaluating cardiac CT angiography (CTA) volume sets. The software packages are designed to support the physician in determining the functional parameters of the left and right ventricles, confirming the presence or absence of physicianidentified myocardial enhancement defects and evaluation documentation and follow-up of any such finding.

Siemens Medical Solutions USA

🏥 Medical Devices Class I - Dangerous

There is a potential risk of a wrong measurement in the annulus plane during a TAVI planning procedure. This risk is due to a software issue found in the TAVI algorithm.

Mar 21, 2019 Diagnostic Equipment Nationwide View Details →

Exprt Precision System: Revision Hip, Proximal Body with Bolt, Lateral Offset, Sterile R, djo surgical, REF: 495-00-065, 495-00-075, 495-00-085, 495-01-065, 495-01-075, 495-01-085

Encore Medical

🏥 Medical Devices Class I - Dangerous

Complaints regarding loose proximal body bolts or bolts that were found through x-ray as sitting above the proximal body and not properly seated. Patient risks may include: pain, dissociation, and possible revision surgery

Sep 21, 2018 Implants & Prosthetics Nationwide View Details →

syngo.via syngo.CT Cardiac Planning, Model Number 10496180 Product Usage: Syngo.CT Cardiac Planning and syngo CT. Cardiac Function are image analysis software packages for evaluating cardiac CT angiography (CTA) volume sets. The software packages are designed to support the physician in determining the functional parameters of the left and right ventricles, confirming the presence or absence of physicianidentified myocardial enhancement defects and evaluation documentation and follow-up of any such finding.

Siemens Medical Solutions USA

🏥 Medical Devices Class I - Dangerous

There is a potential risk of a wrong measurement in the annulus plane during a TAVI planning procedure. This risk is due to a software issue found in the TAVI algorithm.

Mar 21, 2019 Diagnostic Equipment Nationwide View Details →

Gravity IV Set with 3-port Closed Stopcock Manifold Model CS42522E-07

Becton Dickinson & Company

🏥 Medical Devices Class I - Dangerous

The firm has initiated a recall due to a confirmed complaint trend for kinked tubing on the specified lots of the product.

Mar 5, 2019 Infusion Pumps View Details →

Children's loungewear sets

Unknown Manufacturer

🏠 Consumer Products Class II - Moderate

The children's loungewear sets fail to meet the federal flammability standard for children's sleepwear, posing a risk of burn injuries to children.

Apr 17, 2019 Furniture Nationwide View Details →

Portable mini heaters

Unknown Manufacturer

🏠 Consumer Products Class I - Dangerous

The heater can overheat, smoke and catch fire, posing fire and burn hazards.

Apr 17, 2019 Furniture Nationwide View Details →

Craftsman M350 walk-behind lawn mowers

MTD Products Inc of Cleveland, Ohio

🏠 Consumer Products Class II - Moderate

Sharp objects can pierce through the lawn mower's collecting bag during use and strike a user or bystander, posing an injury hazard to consumers.

Apr 17, 2019 Electronics Nationwide View Details →

Children's Bathrobes

H&M Hennes & Mauritz L.P., of New York, N.Y.

🏠 Consumer Products Class II - Moderate

The children's hooded bathrobes fail to meet the flammability standard for children's sleepwear, posing a risk of burn injuries to children.

Apr 15, 2019 Children's Products Nationwide View Details →

All Models of Rock 'n Play Sleeper

Unknown Manufacturer

🏠 Consumer Products Class II - Moderate

Infant fatalities have occurred in Rock 'n Play Sleepers, after the infants rolled from their back to their stomach or side while unrestrained, or under other circumstances.

Apr 12, 2019 Other Consumer Products Nationwide View Details →

Field & Stream Timberline Hang On tree stands

Unknown Manufacturer

🏠 Consumer Products Class II - Moderate

The weld on the seats can break and cause the seat to fall from the tree, posing a fall hazard.

Apr 11, 2019 Other Consumer Products Nationwide View Details →

Specialized Roubaix, Ruby, Diverge, and Sirrus Bicycles with steerer tube collars

Unknown Manufacturer

🏠 Consumer Products Class II - Moderate

The bicycle's steerer tube collar can crack if exposed to corrosion resulting in sudden loss of steering control, posing fall and injury hazards to the rider.

Apr 11, 2019 Sports & Recreation Nationwide View Details →